Combination of Comfrey Root Extract Plus Methyl Nicotinate in Patients with Conditions of Acute Upper or Low Back Pain: A Multicentre Randomised Controlled Trial

This randomised, multicentre, double‐blind, three‐arm, placebo‐controlled trial compared a topical combination of 35% comfrey root extract plus 1.2% methyl nicotinate versus a single preparation of methyl nicotinate or placebo cream for relief of acute upper or low back pain. 379 patients were rando...

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Bibliographic Details
Published in:Phytotherapy research 2013-06, Vol.27 (6), p.811-817
Main Authors: Pabst, Helmut, Schaefer, Axel, Staiger, Christiane, Junker-Samek, Marc, Predel, Hans-Georg
Format: Article
Language:English
Subjects:
acute back pain
Adult
comfrey
Comfrey - chemistry
Double-Blind Method
Female
Humans
Low Back Pain - drug therapy
Male
methyl nicotinate
Nicotinic Acids - therapeutic use
Pain Measurement
Phytotherapy
Plant Extracts - therapeutic use
RCT
Young Adult
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Summary:This randomised, multicentre, double‐blind, three‐arm, placebo‐controlled trial compared a topical combination of 35% comfrey root extract plus 1.2% methyl nicotinate versus a single preparation of methyl nicotinate or placebo cream for relief of acute upper or low back pain. 379 patients were randomly assigned to three groups (combination, n = 163; methyl nicotinate, n = 164; placebo, n = 52). They applied a 12 cm layer of cream three times daily for 5 days. The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. Secondary measures included back pain at rest, pressure algometry, consumption of analgesic medication, functional impairment measured with Oswestry Disability Index, and global assessment of response. The AUC of the VAS on active standardised movement was markedly smaller in the combination treatment group than in the methyl nicotinate and in the placebo group (ANOVA: p 
ISSN:0951-418X
1099-1573
DOI:10.1002/ptr.4790